Neuropathic PainNCT03060122
Combining CES Alpha-Stim and InterX for Optimized Rehabilitation Following Extremity Immobilization
A study testing NIN and CES in people with Neuropathic Pain, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
This study will be aimed at assessing the feasibility of a dual-device treatment prior to a rehabilitation session for an orthopaedic injury requiring immobilization, and its impact on improving outcomes and decreasing the risk for development of neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- NIN and CES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 7 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An orthopaedic/musculoskeletal postoperative injury that required cast or splint immobilization of the joint(s) to be treated of ≥ 2 weeks and available for treatment and are coming in for physical or occupational therapy
- Between the age of 18 - 65 years
- Read and speak English well enough to provide informed consent and follow study instructions
Who cannot join
- Active infection, open sores, or open incisions (or anything that would inhibit the application of the stim) in the affected extremity.
- Any contraindications to electrical stimulation including: any type of implanted demand type cardiac pacemakers, implanted defibrillators, or implanted functioning devices (i.e., insulin pump); active cancerous tissue or are undergoing chemotherapy; known pregnancy or breastfeeding or history of epilepsy or other seizures.
- History of inflammatory skin diseases (psoriasis, dermatitis, etc.).
- Contralateral extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 75234
About this study
Official title: The Clinical Feasibility of Combining Cranial Electrotherapy Stimulation (CES Alpha-Stim) and Non-invasive Interactive Neurostimulation (InterX) for Optimized Rehabilitation Following Extremity Immobilization
This study will be aimed at assessing the feasibility of a dual-device treatment prior to a rehabilitation session for an orthopaedic injury requiring immobilization, and its impact on improving outcomes and decreasing the risk for development of neuropathic pain. The investigators will evaluate the clinical feasibility and effectiveness of incorporating the Alpha-Stim and Inter-X treatment into a standard rehabilitation protocol to address risk factors associated with the development of neuropathic pain (i.e., pain, range of motion, and skin temperature) as well as its impact on reduced pain medication.
Read the detailed description
Once patients provide consent and we have determined that they meet inclusion criteria the process will occur as follows:
- Participants will be administered baseline demographic and standard medical history questionnaires, including information about prescription medication use. In addition, participants will fill out baseline self-report outcomes and be administered the (LANSS) Pain Scale. Range of motion and temperature will also be assessed during the initial session. Some of these measurements are standard of care and would be filled out by the participant even if the participant were not participating in the study.
Usual CARE The usual care aspect of this study is the delivery of the pain treatment (NIN and CES) as is commonly used at the Center for the Intrepid. The experimental aspect is the combined delivery of the treatment, and the use of sham treatment as a control. The treatment (NIN and CES) will be delivered in a pragmatic fashion, with treatment delivered in conjunction with rehab visits and lasting approximately 4-weeks total. Each session will last approximately 20-40 minutes long, and will most often be delivered in conjunction with their rehab visit (physical therapy or occupational therapy) that occurs anywhere from 1 to 3 times each week.
STRICTLY RESEARCH The experimental aspect of the study will be the comparison of combined treatment (NIN + CES), standard NIN with sham CES, to standard care alone. Before initiation of treatment participants will be randomized to either NIN + CES, NIN + Sham CES, or standard care only immediately after the immobilization device (cast, brace, etc) has been removed. Randomization with be performed with a random number gerator. All groups will continue with their own rehabilitation as indicated throughout the entire course of the study treatment, and beyond as indicated by their therapist. The investigators will keep track of rehab appointments and visits, but not control for them.
- At the 1-month follow-up, all participants will fill out the same self-report outcome measures from baseline, to include prescription pain medication and be administered the LANSS pain scale. Range of motion and temperature will also be assessed.
- At the 2 and 4-month follow-up the same assessments will again be administered. If the participant has completed formal therapy prior to the 2 and 4 month follow-up time points the participant will be asked to return to the clinic to complete these assessments. Participants may be contacted by telephone or email, if agreeable, to provide a reminder for the return appointment(s).
- Outcomes will be compared between the three groups at each time point (i.e., initial, one month, two months, four months).
- All participants will be followed out to 4 months.
Although every attempt will be made to collect data at these specific times, due to the variability of participant and clinic schedules, the actual timing of collection may vary (+/- 1 week) and some of the proposed measures may not be collected at all time points.
- Conditions
- Neuropathic Pain
- Being tested
- NIN, Sham CES, CES
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NINDevice
Also called InterX
The InterX device will be applied by a trained therapist along the course of the dermatomes in the affected area, paying special attention to the location of major cutaneous nerves ensuring optimal treatment points are identified and treated within the neurologically related area.
Sham CESDevice
Also called Alpha-Stim Sham
The sham CES is identical to the regular device but ear clips will emit a dose at 100 mA, a sub-sensory level.
CESDevice
Also called Alpha-Stim
Cranial Electrical Stimulation (CES) Alpha-Stim is a noninvasive medical treatment device that delivers a microcurrent (100 to 500 microamperes) via ear clip electrodes connected to a handheld device.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Patient's randomized to this arm will receive standard post operative/post immobilization physical therapy or occupational therapy rehabilitation care without the use of NIN or CES. |
| NIN (InterX) and CES (Alpha-Stim) | Experimental | The Alpha-Stim Cranial Electrical Stimulation device applies a micro-current trans-cranially via electrodes attached to the ear.The electrical current is controlled through a handheld device. Standard treatment sessions lasting approximately 20-60 minutes.
InterX Therapy (non-invasive) has been developed specifically for the treatment of acute and chronic pain. It is delivered on the skin of the involved area. The device will be applied by a trained therapist along the course of the dermatomes in the affected area. Electrical current is controlled through a handheld device. Standard treatment sessions last approx 20-45 min.
The treatment will be delivered in conjunction with the rehab visit (physical or occupational therapy) Receives: Device: NIN; Device: CES |
| NIN (InterX) and sham CES | Active comparator | The Alpha-Stim Cranial Electrical Stimulation device intensity will be preset and locked by the manufacturer at its lowest therapeutic dose at 100 mA, a sub-sensory level that serves as a sham treatment.
InterX Therapy (non-invasive) has been developed specifically for the treatment of acute and chronic pain. It is delivered on the skin of the involved area. The device will be applied by a trained therapist along the course of the dermatomes in the affected area.Electrical current is controlled through a handheld device. Standard treatment sessions last approx 20-45 min.
The treatment will be delivered in conjunction with the rehab visit (physical or occupational therapy) Receives: Device: NIN; Device: Sham CES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
An 11-point verbalize NRS will be used to assess the subject's upper or lower extremity pain the day of each assessment as well as during therapy sessions. The 0 to 10 NPS has been found to be valid and reliable in many patient populations including the musculoskeletal population[37] and has been recommended for inclusion in the core NIH Toolbox for use with adults[38].
Measured: 4 months
Secondary outcomes (8)
Temperature
The temperature at three locations (different for upper and lower extremity) will be recorded with an infrared thermometer (Exergen DT-1001RS Infrared Dermal Thermometer with Remote Sensor, Exergen Corp, Watertown, Massachusetts) on both the involved and uninvolved extremities.
Measured: 4 months
Range of Motion (ROM)
Active and/or passive ROM of the involved joints will be assessed using an electronic goniometer, and the reference of "normal" will be the non-involved limb. A measurement will be taken, but also the result will be dichotomously categorized as within 95% of opposite side - YES or NO.
Measured: 4 months
Pain Medication
An 11-point verbalize NRS will be used to assess the subject's upper or lower extremity pain the day of each assessment as well as during therapy sessions. The 0 to 10 NPS has been found to be valid and reliable in many patient populations including the musculoskeletal population[37] and has been recommended for inclusion in the core NIH Toolbox for use with adults[38].
Measured: 4 months
Global Rating of Change (GRC)
The GRC, a self-report instrument, assesses subjective perception of the efficacy of a particular treatment and the significance of that change [39]. A 15-point Likert type scale ranging from 1 (very great deal worse) to 15 (a very great deal better) and a 6-point Likert type scale ranging from 1 (a tiny bit important) to 6 (a very great important) will be used. The GRC is used to determine the minimal clinically important differences and will be used in this study to assess the participants' perceived magnitude of changes following the 30 minute combined NIN/CES treatment and again after each physical therapy or occupational therapy session for range of motion and pain.
Measured: 4 months
The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale
The LANNS assessment helps identify whether or not a patient exhibits neuropathic pain. The instrument consists of five self-report and two clinician administered sensory function items that assess dynamic mechanical allodynia and altered pin-prick threshold (PPT). Weighted scores for the seven items are binary (yes or no) and summed, giving a total score between 0 and 24. In terms of diagnostic validity, during the validation study this assessment yielded a sensitivity of 85% and specificity of 80%[
Measured: 4 months
National Institutes of Health Patient Reported Outcomes Measurement Information Systems (PROMIS) 29
Emotional The PROMIS 29, a self-reported measure, assesses health-related quality of life (HRQOL) in seven domains (physical function, anxiety, depression, fatigue, sleep disturbance, social role satisfaction, pain interference, pain intensity). The instrument utilizes a 7-day recall period and consists of eight questions on a Likert-type scale, ranging from 1 to 5 , except for the pain intensity scale, which ranges from 0 to 10.
Measured: 4 months
Lower Extremity Functional Scale(LEFS)
The LEFS, originally described by Binkley et al, provides global assessment of function related specifically to the lower extremities.[50] It is one self-report outcome measure that can capture adverse impact on function from multiple injuries or specific locations in the lower extremity. It consists of 20 questions total related to functional activities, each with a possible score ranging from 0 to 4, where 0 indicates that the activity cannot be performed at all and 4 indicates that the activity be performed with no limitations. The total maximum score is 80 points, indicating no limitations with any of the functional tasks. It has been shown to be valid, reliable, and responsive to change in various patient populations and in different body regions in the lower extremity (ankle, knee, and hip).[50-52]
Measured: 4 months
Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH
The DASH is an 11-item self-report measure that assesses a subject's perceived ability to complete twenty-one upper extremity functional activities using a 5-point Likert scale. The cumulative Quick DASH score is scaled from 0 to 100, with higher scores indicating increased disability. The DASH is well tested and has been validated and found reliable in many different upper limb musculoskeletal disorders[45-48]. The Minimally Clinically Important Difference (MCID) for the Dash is 10.83 points, and for the QuickDash is 15.91 points.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2018
- Primary completion31 Jul 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Benjamin Keizer, Brooke Army Medical Center
- Investigators
- Jill Cancio, OTD, Study director, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060122
- Sponsor's protocol ID
- C.2017.026
- Status last verified
- Nov 2019
- First submitted
- 17 Feb 2017
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koltzenburg M. Neural mechanisms of cutaneous nociceptive pain. Clin J Pain. 2000 Sep;16(3 Suppl):S131-8. doi: 10.1097/00002508-200009001-00004.
PubMed 11014457Trescot AM, Helm S, Hansen H, Benyamin R, Glaser SE, Adlaka R, Patel S, Manchikanti L. Opioids in the management of chronic non-cancer pain: an update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines. Pain Physician. 2008 Mar;11(2 Suppl):S5-S62.
PubMed 18443640Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.
PubMed 14622770Webster BS, Verma SK, Gatchel RJ. Relationship between early opioid prescribing for acute occupational low back pain and disability duration, medical costs, subsequent surgery and late opioid use. Spine (Phila Pa 1976). 2007 Sep 1;32(19):2127-32. doi: 10.1097/BRS.0b013e318145a731.
PubMed 17762815Hortobagyi T, Dempsey L, Fraser D, Zheng D, Hamilton G, Lambert J, Dohm L. Changes in muscle strength, muscle fibre size and myofibrillar gene expression after immobilization and retraining in humans. J Physiol. 2000 Apr 1;524 Pt 1(Pt 1):293-304. doi: 10.1111/j.1469-7793.2000.00293.x.
PubMed 10747199Brandt KD. Response of joint structures to inactivity and to reloading after immobilization. Arthritis Rheum. 2003 Apr 15;49(2):267-71. doi: 10.1002/art.11009. No abstract available.
PubMed 12687522Nigam AK, Taylor DM, Valeyeva Z. Non-invasive interactive neurostimulation (InterX) reduces acute pain in patients following total knee replacement surgery: a randomised, controlled trial. J Orthop Surg Res. 2011 Aug 24;6:45. doi: 10.1186/1749-799X-6-45.
PubMed 21864362Gorodetskyi IG, Gorodnichenko AI, Tursin PS, Reshetnyak VK, Uskov ON. Non-invasive interactive neurostimulation in the post-operative recovery of patients with a trochanteric fracture of the femur. A randomised, controlled trial. J Bone Joint Surg Br. 2007 Nov;89(11):1488-94. doi: 10.1302/0301-620X.89B11.19352.
PubMed 17998187Gorodetskyi IG, Gorodnichenko AI, Tursin PS, Reshetnyak VK, Uskov ON. Use of noninvasive interactive neurostimulation to improve short-term recovery in patients with surgically repaired bimalleolar ankle fractures: a prospective, randomized clinical trial. J Foot Ankle Surg. 2010 Sep-Oct;49(5):432-7. doi: 10.1053/j.jfas.2010.05.007. Epub 2010 Aug 5.
PubMed 20688546Kirsch DL, Smith RB. The use of cranial electrotherapy stimulation in the management of chronic pain: A review. NeuroRehabilitation. 2000;14(2):85-94.
PubMed 11455071Smith RB, Tiberi A, Marshall J. The use of cranial electrotherapy stimulation in the treatment of closed-head-injured patients. Brain Inj. 1994 May-Jun;8(4):357-61. doi: 10.3109/02699059409150986.
PubMed 8081350Taylor AG, Anderson JG, Riedel SL, Lewis JE, Bourguignon C. A randomized, controlled, double-blind pilot study of the effects of cranial electrical stimulation on activity in brain pain processing regions in individuals with fibromyalgia. Explore (NY). 2013 Jan-Feb;9(1):32-40. doi: 10.1016/j.explore.2012.10.006.
PubMed 23294818Cook KF, Dunn W, Griffith JW, Morrison MT, Tanquary J, Sabata D, Victorson D, Carey LM, Macdermid JC, Dudgeon BJ, Gershon RC. Pain assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S49-53. doi: 10.1212/WNL.0b013e3182872e80.
PubMed 23479545
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Feasibility of Combining Cranial Electrotherapy Stimulation (CES Alpha-Stim) and Non-invasive Interactive Neurostimulation (InterX) for Optimized Rehabilitation Following Extremity Immobilization
- ClinicalTrials.gov ID
- NCT03060122
- Acronym / sponsor ID
- C.2017.026
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be aimed at assessing the feasibility of a dual-device treatment prior to a rehabilitation session for an orthopaedic injury requiring immobilization, and its impact on improving outcomes and decreasing the risk for development of neuropathic pain. The investigators will evaluate the clinical feasibility and effectiveness of incorporating the Alpha-Stim and Inter-X treatment into a standard rehabilitation protocol to address risk factors associated with the development of neuropathic pain (i.e., pain, range of motion, and skin temperature) as well as its impact on reduced pain medication.
Detailed description
Once patients provide consent and we have determined that they meet inclusion criteria the process will occur as follows:
- Participants will be administered baseline demographic and standard medical history questionnaires, including information about prescription medication use. In addition, participants will fill out baseline self-report outcomes and be administered the (LANSS) Pain Scale. Range of motion and temperature will also be assessed during the initial session. Some of these measurements are standard of care and would be filled out by the participant even if the participant were not participating in the study.
Usual CARE The usual care aspect of this study is the delivery of the pain treatment (NIN and CES) as is commonly used at the Center for the Intrepid. The experimental aspect is the combined delivery of the treatment, and the use of sham treatment as a control. The treatment (NIN and CES) will be delivered in a pragmatic fashion, with treatment delivered in conjunction with rehab visits and lasting approximately 4-weeks total. Each session will last approximately 20-40 minutes long, and will most often be delivered in conjunction with their rehab visit (physical therapy or occupational therapy) that occurs anywhere from 1 to 3 times each week.
STRICTLY RESEARCH The experimental aspect of the study will be the comparison of combined treatment (NIN + CES), standard NIN with sham CES, to standard care alone. Before initiation of treatment participants will be randomized to either NIN + CES, NIN + Sham CES, or standard care only immediately after the immobilization device (cast, brace, etc) has been removed. Randomization with be performed with a random number gerator. All groups will continue with their own rehabilitation as indicated throughout the entire course of the study treatment, and beyond as indicated by their therapist. The investigators will keep track of rehab appointments and visits, but not control for them.
- At the 1-month follow-up, all participants will fill out the same self-report outcome measures from baseline, to include prescription pain medication and be administered the LANSS pain scale. Range of motion and temperature will also be assessed.
- At the 2 and 4-month follow-up the same assessments will again be administered. If the participant has completed formal therapy prior to the 2 and 4 month follow-up time points the participant will be asked to return to the clinic to complete these assessments. Participants may be contacted by telephone or email, if agreeable, to provide a reminder for the return appointment(s).
- Outcomes will be compared between the three groups at each time point (i.e., initial, one month, two months, four months).
- All participants will be followed out to 4 months.
Although every attempt will be made to collect data at these specific times, due to the variability of participant and clinic schedules, the actual timing of collection may vary (+/- 1 week) and some of the proposed measures may not be collected at all time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Patient's randomized to this arm will receive standard post operative/post immobilization physical therapy or occupational therapy rehabilitation care without the use of NIN or CES. |
| NIN (InterX) and CES (Alpha-Stim) | Experimental | Device: NIN, Device: CESThe Alpha-Stim Cranial Electrical Stimulation device applies a micro-current trans-cranially via electrodes attached to the ear.The electrical current is controlled through a handheld device. Standard treatment sessions lasting approximately 20-60 minutes. InterX Therapy (non-invasive) has been developed specifically for the treatment of acute and chronic pain. It is delivered on the skin of the involved area. The device will be applied by a trained therapist along the course of the dermatomes in the affected area. Electrical current is controlled through a handheld device. Standard treatment sessions last approx 20-45 min. The treatment will be delivered in conjunction with the rehab visit (physical or occupational therapy) |
| NIN (InterX) and sham CES | Active comparator | Device: NIN, Device: Sham CESThe Alpha-Stim Cranial Electrical Stimulation device intensity will be preset and locked by the manufacturer at its lowest therapeutic dose at 100 mA, a sub-sensory level that serves as a sham treatment. InterX Therapy (non-invasive) has been developed specifically for the treatment of acute and chronic pain. It is delivered on the skin of the involved area. The device will be applied by a trained therapist along the course of the dermatomes in the affected area.Electrical current is controlled through a handheld device. Standard treatment sessions last approx 20-45 min. The treatment will be delivered in conjunction with the rehab visit (physical or occupational therapy) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- An orthopaedic/musculoskeletal postoperative injury that required cast or splint immobilization of the joint(s) to be treated of ≥ 2 weeks and available for treatment and are coming in for physical or occupational therapy
- Between the age of 18 - 65 years
- Read and speak English well enough to provide informed consent and follow study instructions
Key exclusion criteria (4 listed)
- Active infection, open sores, or open incisions (or anything that would inhibit the application of the stim) in the affected extremity.
- Any contraindications to electrical stimulation including: any type of implanted demand type cardiac pacemakers, implanted defibrillators, or implanted functioning devices (i.e., insulin pump); active cancerous tissue or are undergoing chemotherapy; known pregnancy or breastfeeding or history of epilepsy or other seizures.
- History of inflammatory skin diseases (psoriasis, dermatitis, etc.).
- Contralateral extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NINAlso: InterXThe InterX device will be applied by a trained therapist along the course of the dermatomes in the affected area, paying special attention to the location of major cutaneous nerves ensuring optimal treatment points are identified and treated within the neurologically related area. | Device | NIN (InterX) and CES (Alpha-Stim), NIN (InterX) and sham CES |
| Sham CESAlso: Alpha-Stim ShamThe sham CES is identical to the regular device but ear clips will emit a dose at 100 mA, a sub-sensory level. | Device | NIN (InterX) and sham CES |
| CESAlso: Alpha-StimCranial Electrical Stimulation (CES) Alpha-Stim is a noninvasive medical treatment device that delivers a microcurrent (100 to 500 microamperes) via ear clip electrodes connected to a handheld device. | Device | NIN (InterX) and CES (Alpha-Stim) |
Primary outcome
Pain Intensity
Time frame: 4 months
An 11-point verbalize NRS will be used to assess the subject's upper or lower extremity pain the day of each assessment as well as during therapy sessions. The 0 to 10 NPS has been found to be valid and reliable in many patient populations including the musculoskeletal population[37] and has been recommended for inclusion in the core NIH Toolbox for use with adults[38].
8 secondary outcomes
Temperature
Time frame: 4 months
Range of Motion (ROM)
Time frame: 4 months
Pain Medication
Time frame: 4 months
Global Rating of Change (GRC)
Time frame: 4 months
The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale
Time frame: 4 months
National Institutes of Health Patient Reported Outcomes Measurement Information Systems (PROMIS) 29
Time frame: 4 months
Lower Extremity Functional Scale(LEFS)
Time frame: 4 months
Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Background: PubMed 11014457Koltzenburg M. Neural mechanisms of cutaneous nociceptive pain. Clin J Pain. 2000 Sep;16(3 Suppl):S131-8. doi: 10.1097/00002508-200009001-00004.
- Background: PubMed 18443640Trescot AM, Helm S, Hansen H, Benyamin R, Glaser SE, Adlaka R, Patel S, Manchikanti L. Opioids in the management of chronic non-cancer pain: an update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines. Pain Physician. 2008 Mar;11(2 Suppl):S5-S62.
- Background: PubMed 14622770Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.
- Background: PubMed 17762815Webster BS, Verma SK, Gatchel RJ. Relationship between early opioid prescribing for acute occupational low back pain and disability duration, medical costs, subsequent surgery and late opioid use. Spine (Phila Pa 1976). 2007 Sep 1;32(19):2127-32. doi: 10.1097/BRS.0b013e318145a731.
- Background: PubMed 10747199Hortobagyi T, Dempsey L, Fraser D, Zheng D, Hamilton G, Lambert J, Dohm L. Changes in muscle strength, muscle fibre size and myofibrillar gene expression after immobilization and retraining in humans. J Physiol. 2000 Apr 1;524 Pt 1(Pt 1):293-304. doi: 10.1111/j.1469-7793.2000.00293.x.
- Background: PubMed 12687522Brandt KD. Response of joint structures to inactivity and to reloading after immobilization. Arthritis Rheum. 2003 Apr 15;49(2):267-71. doi: 10.1002/art.11009. No abstract available.
- Background: PubMed 21864362Nigam AK, Taylor DM, Valeyeva Z. Non-invasive interactive neurostimulation (InterX) reduces acute pain in patients following total knee replacement surgery: a randomised, controlled trial. J Orthop Surg Res. 2011 Aug 24;6:45. doi: 10.1186/1749-799X-6-45.
- Background: PubMed 17998187Gorodetskyi IG, Gorodnichenko AI, Tursin PS, Reshetnyak VK, Uskov ON. Non-invasive interactive neurostimulation in the post-operative recovery of patients with a trochanteric fracture of the femur. A randomised, controlled trial. J Bone Joint Surg Br. 2007 Nov;89(11):1488-94. doi: 10.1302/0301-620X.89B11.19352.
- Background: PubMed 20688546Gorodetskyi IG, Gorodnichenko AI, Tursin PS, Reshetnyak VK, Uskov ON. Use of noninvasive interactive neurostimulation to improve short-term recovery in patients with surgically repaired bimalleolar ankle fractures: a prospective, randomized clinical trial. J Foot Ankle Surg. 2010 Sep-Oct;49(5):432-7. doi: 10.1053/j.jfas.2010.05.007. Epub 2010 Aug 5.
- Background: PubMed 11455071Kirsch DL, Smith RB. The use of cranial electrotherapy stimulation in the management of chronic pain: A review. NeuroRehabilitation. 2000;14(2):85-94.
- Background: PubMed 8081350Smith RB, Tiberi A, Marshall J. The use of cranial electrotherapy stimulation in the treatment of closed-head-injured patients. Brain Inj. 1994 May-Jun;8(4):357-61. doi: 10.3109/02699059409150986.
- Background: PubMed 23294818Taylor AG, Anderson JG, Riedel SL, Lewis JE, Bourguignon C. A randomized, controlled, double-blind pilot study of the effects of cranial electrical stimulation on activity in brain pain processing regions in individuals with fibromyalgia. Explore (NY). 2013 Jan-Feb;9(1):32-40. doi: 10.1016/j.explore.2012.10.006.
- Individual participant dataSharing planned: No
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Cancer Pain, Orofacial Pain
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Cancio, OTD study director
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIN and CES in people with Neuropathic Pain, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03060122, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.